Application Information

This drug has been submitted to the FDA under the reference 017376/002.

Names and composition

"SEPTRA DS" is the commercial name of a drug composed of SULFAMETHOXAZOLE and TRIMETHOPRIM.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
017376/002 SEPTRA DS SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 800MG and 160MG

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
017376/001 SEPTRA SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 400MG and 80MG
017376/002 SEPTRA DS SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 800MG and 160MG
017377/001 BACTRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 400MG and 80MG
017377/002 BACTRIM DS SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 800MG and 160MG
017560/001 BACTRIM SULFAMETHOXAZOLE; TRIMETHOPRIM SUSPENSION/ORAL 200MG per 5ML and 40MG per 5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
017560/002 BACTRIM PEDIATRIC SULFAMETHOXAZOLE; TRIMETHOPRIM SUSPENSION/ORAL 200MG per 5ML and 40MG per 5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
017598/001 SEPTRA SULFAMETHOXAZOLE; TRIMETHOPRIM SUSPENSION/ORAL 200MG per 5ML and 40MG per 5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
017598/002 SEPTRA GRAPE SULFAMETHOXAZOLE; TRIMETHOPRIM SUSPENSION/ORAL 200MG per 5ML and 40MG per 5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
018242/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 400MG and 80MG
018242/002 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 800MG and 160MG
018374/001 BACTRIM SULFAMETHOXAZOLE; TRIMETHOPRIM INJECTABLE/INJECTION 80MG per ML and 16MG per ML
018452/001 SEPTRA SULFAMETHOXAZOLE; TRIMETHOPRIM INJECTABLE/INJECTION 80MG per ML and 16MG per ML
018598/003 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 400MG and 80MG
018598/004 SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 800MG and 160MG
018615/001 SULFATRIM PEDIATRIC SULFAMETHOXAZOLE; TRIMETHOPRIM SUSPENSION/ORAL 200MG per 5ML and 40MG per 5ML
018615/002 SULFATRIM SULFAMETHOXAZOLE; TRIMETHOPRIM SUSPENSION/ORAL 200MG per 5ML and 40MG per 5ML
018812/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM SUSPENSION/ORAL 200MG per 5ML and 40MG per 5ML
018812/002 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM SUSPENSION/ORAL 200MG per 5ML and 40MG per 5ML
018852/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 400MG and 80MG
018854/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 800MG and 160MG
018946/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 400MG and 80MG
018946/002 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 800MG and 160MG
070000/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 800MG and 160MG
070002/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 400MG and 80MG
070006/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 400MG and 80MG
070007/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 800MG and 160MG
070022/001 SULFAMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 400MG and 80MG
070028/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM SUSPENSION/ORAL 200MG per 5ML and 40MG per 5ML
070030/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 400MG and 80MG
070032/001 SULFAMETHOPRIM-DS SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 800MG and 160MG
070034/001 COTRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 400MG and 80MG
070037/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 800MG and 160MG
070048/001 COTRIM D.S. SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 800MG and 160MG
070063/001 SULMEPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM SUSPENSION/ORAL 200MG per 5ML and 40MG per 5ML
070064/001 SULMEPRIM PEDIATRIC SULFAMETHOXAZOLE; TRIMETHOPRIM SUSPENSION/ORAL 200MG per 5ML and 40MG per 5ML
070065/002 SULFATRIM-SS SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 400MG and 80MG
070066/001 SULFATRIM-DS SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 800MG and 160MG
070203/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 400MG and 80MG
070204/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 800MG and 160MG
070215/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 400MG and 80MG
070216/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 800MG and 160MG
070223/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM INJECTABLE/INJECTION 80MG per ML and 16MG per ML
070627/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM INJECTABLE/INJECTION 80MG per ML and 16MG per ML
070628/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM INJECTABLE/INJECTION 80MG per ML and 16MG per ML
070889/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 400MG and 80MG
070890/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 800MG and 160MG
071016/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 400MG and 80MG
071017/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 800MG and 160MG
071299/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 400MG and 80MG
071300/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 800MG and 160MG
071341/001 SULFAMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM Injectable/ Injection 80MG per ML and 16MG per ML
071556/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM INJECTABLE/INJECTION 80MG per ML and 16MG per ML
071815/001 UROPLUS SS SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 400MG and 80MG
071816/001 UROPLUS DS SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 800MG and 160MG
072289/001 TRIMETH/SULFA SULFAMETHOXAZOLE; TRIMETHOPRIM SUSPENSION/ORAL 200MG per 5ML and 40MG per 5ML
072383/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM INJECTABLE/INJECTION 80MG per ML and 16MG per ML
072398/001 TRIMETH/SULFA SULFAMETHOXAZOLE; TRIMETHOPRIM SUSPENSION/ORAL 200MG per 5ML and 40MG per 5ML
072399/001 TRIMETH/SULFA SULFAMETHOXAZOLE; TRIMETHOPRIM SUSPENSION/ORAL 200MG per 5ML and 40MG per 5ML
072408/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 400MG and 80MG
072417/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 800MG and 160MG
072768/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 400MG and 80MG
072769/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 800MG and 160MG
073199/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM INJECTABLE/INJECTION 80MG per ML and 16MG per ML
073303/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM INJECTABLE/INJECTION 80MG per ML and 16MG per ML
074650/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM SUSPENSION/ORAL 200MG per 5ML and 40MG per 5ML
076817/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 400MG and 80MG
076817/002 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 800MG and 160MG
076899/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 400MG and 80MG
076899/002 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 800MG and 160MG
077612/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM SUSPENSION/ORAL 200MG per 5ML and 40MG per 5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
077785/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM SUSPENSION/ORAL 200MG per 5ML and 40MG per 5ML
078060/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 800MG and 160MG
078060/002 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 400MG and 80MG
090624/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 400MG and 80MG
090624/002 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 800MG and 160MG
090828/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 800MG and 160MG
090828/002 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET/ORAL 400MG and 80MG
091348/001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM SUSPENSION/ORAL 200MG per 5ML and 40MG per 5ML

Ask a doctor

A licensed doctor will try to answer your question for free as quickly as possible. Free of charge during the beta period.

Answered questions

Septra ds antibiotic and sudden leg/muscle pain?
I started septra 3 days ago and today the muscles of my right leg hurt so muchhh. I havent been alble to sleep at all! It especially hurts on my upper thigh. Ive been very nauseus and tired and now in pain...is this normal? should I go to the doctor? can it cause muscle spasms? I really havent done any physical... Asked by Noella Yanish 1 year ago.

I started septra 3 days ago and today the muscles of my right leg hurt so muchhh. I havent been alble to sleep at all! It especially hurts on my upper thigh. Ive been very nauseus and tired and now in pain...is this normal? should I go to the doctor? can it cause muscle spasms? I really havent done any physical activity. Thanks! Answered by Fiona Angeline 1 year ago.

Yes, it could be Septra that is causing it. All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Septra: Appetite loss; nausea; vomiting. Seek medical attention right away if any of these SEVERE side effects occur when using Septra: Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blistered, peeling, red, or swollen skin; bloody or black, tarry stools; chest pain; chills, fever, or sore throat; decreased urination; depression; hallucinations; irregular heartbeat; *joint or muscle pain*; painful or stiff neck; purple patches under the skin; seizures; severe diarrhea; severe or persistent cough; severe or persistent headache; severe or persistent nausea or vomiting; shortness of breath; stomach cramps/pain; unusual bruising or bleeding; unusual tiredness or weakness; unusually pale skin; vaginal irritation or discharge; yellowing of the skin or eyes. : ( Answered by Taryn Cruise 1 year ago.

Septra Ds Antibiotic Answered by Sherryl Miras 1 year ago.


Is septra ds doing this to me?
FYI i do take the right dosage, just saying. Asked by Eddy Hammang 1 year ago.

Ok, so I have a toenail infection (I know, gross) And I've been taking a substitute for septra ds. It's just a bunch of little things I'm wondering about, like in athletics when I'm running it's kinda harder to breathe than normal, and I'm bruising real easily now. I play marching bass drum, and when I first started, i had bruises from the harness, and they went away, but now I'm getting them again. and bruises basicially if someone touches me haha. I've also been sweating a lot, and now I'm shivering, like I'm cold. I've also had really bad headaches. ? Just wondering if it's the medicine or what, please don't tell me to go see a doctor. Answered by Gale Lautenbach 1 year ago.

It sounds like Septra is not a medication you should be taking. Many people have allergic reactions to the sulfonamide class of antibiotics of which Septra DS is a member. The bruising and difficulty breathing are two of the signs (the breathing difficulty in particular) of allergic reaction to this medication. There are other options to treat your infection. Sorry, but you do need to call your doctor. Answered by Francisco Siske 1 year ago.


Can you become immune to Septra DS?
I take a septra ds tablet every day for acne for the past year. The doctor tried to take me off over the summer and my acne got worse. Can the break in taking the pill cause me tobe immune. Asked by Lourie Nakamura 1 year ago.

people do not become immune to antibiotics. bacteria become resistant to antibiotics. By definition, just about every bacteria on you and in you is resistant to Septra, because you've been taking it for the past year. If the bacteria were NOT resistant, they could not be living on you. But the important thing is , for you, that this antibiotics has reasonably good activity against propionibacterium, the bugs that cause acne. So it is inhibiting growth of them, and making your acne. Continue to take it. There is no harm at periodically stopping it to see what happens. How else would you know if you still need it or not? Your goal is to get off of it as soon as you can, but be aware that this drug is safe to take for years at a time. Answered by Shanda Woodfield 1 year ago.

You do not become immune, but the bacteria the antibiotics are treating become immune (acne has a bacterial component). Answered by Salena Plymire 1 year ago.

Well all i know is that if you take a pill so many times, your body will be used to it, and not have the same effect anymore. So maybe that's it, i didn't really answer your question wel maybe i did I'm not sure i understand the question Answered by Hilaria Baek 1 year ago.

yupp.. i would thikn so dont know for usre tho Answered by Cameron Hamdan 1 year ago.


My staff infection is not completely gone and i run out of tetracycline and septra D tomorrow?
I recently got a staff infection and the doctor presribed me two antibiotics for it, i have to take both twice daily for 7 days tomorrow i run out of medicine but there are a few spots that are still swollen but most are just scars... will i be fine or should i go back to the doctors to prevent it from growing again? Asked by Elwanda Caraher 1 year ago.

You'll want to have the staph infection under control, so you definitely want to contact the doctor who prescribed the meds. Having been on antibiotics and the infection has not completely healed can cause the infection to "mutate" and become more severe and harder to treat. CALL your doctor!!! That is the only person who can prescribe the meds and keep the infection from getting worse! Answered by Antonia Mroz 1 year ago.

I'm wondering why your taking tetracycline for a staph infection, the usual course for staph is from the penicillin family unless you're allergic to them.You need to go back as long as there is any form of the infection still there. Answered by Burl Appleberry 1 year ago.

Go back to the doc for a checkup just in case. Sometimes Staph infections need more than one course of antibiotics. Answered by Kevin Mcnertney 1 year ago.

Call the doctor's office and let them know that you still have some symptoms. They may want to prescribe more antibiotics. Answered by Humberto Raygoza 1 year ago.


I'm taking septra ds for a so called infection in prostate, I took one pill and now have flu symps low bk pain?
I'm in a lot of pain I went to the ER they sent me back home ten min later just telling me to finish my antibiotics wtf I'm in so much pain. Asked by Azzie Schouweiler 1 year ago.

Call your pharmacist. He or she will know if that is a serious reaction to the medication. (Or call any pharmacy that is open and ask to speak to a pharmacist.) Answered by Herlinda Wnek 1 year ago.


When should I start tracking ovulation again?
So the past couple of months I have been sick alot with upper respitory infections and tonsilitis and ear infections. On top of all of that I have a severe bladder infection which is getting better now. It has two months since I had a period. This is odd to me because I am NEVER late and always on time...just like... Asked by Vivian Terstage 1 year ago.

So the past couple of months I have been sick alot with upper respitory infections and tonsilitis and ear infections. On top of all of that I have a severe bladder infection which is getting better now. It has two months since I had a period. This is odd to me because I am NEVER late and always on time...just like clock work. As soon as I started the prescription of Septra DS, I started my period. My cycles are 34 days. I started on September 11th. My husband and I are trying to concieve, but now I'm lost of how to track. How will I do this? Please help? I thought we were preggo when I didn't get my period for over a month. It's heart breaking when I come up to the time I suppose to start and actually start when we have been trying and trying. Please send baby good lucks! thanks in advanced! Answered by Polly Constancio 1 year ago.

Where are you getting the information approximately your ovulation? If it's from a web page, I might endorse OPKs or temping. The purpose why is that I relied on that I used to be to ovulate on day 14 reason that is what each person says, and TTC for three years, eventually deciding that I did not ovulate till day 20. But, if you're certain that this ovulation list is correct for you, then to reply your query, I might have intercourse each different day beginning with day 21. Best of success! Answered by Valeria Follis 1 year ago.


Absorption time for septra/bactrim (antibiotics)?
I took some vicodin and septra ds/bactrim ds this morning at 8. It's now 11. The doctor said the antibiotics take 12 hours to get into my system. The vicodin is making me really sick. If I throw up, should I take more antibiotics? Asked by Emily Weinreich 1 year ago.

No, you don't need to take another dose. The drug is absorbed much more quickly than 12 hours, that's not what your doctor meant. The DS form of the product is dosed every 12 hours, and has a half-life of 6-12 hours. If you can keep it down at least 15-20 minutes, don't take it again. Answered by Ginny Vlahos 1 year ago.

sounds such as you have developed hemmoroids. you may attempt a trouble-loose attempt to make certain this subject. Take a tissue and dab on a drop of Chlorine Bleach. Dab the tissue on the affected area. this could stop the diarrhea over night. Answered by Ericka Beene 1 year ago.

never take more antibotics then what it says even if you throw up...make sure you have some crackers or toaste before you take your vicdon because it can make you sick on a empty stomach..alwaso dont take them together..take them at least a hour apart. Answered by Sharron Matchette 1 year ago.


Question about the antibiotic bactrim and septra?
I am on bactrim ds. I was just on septra 3 months ago. Are these 2 the same drug? If I'm not allergix to septra could I be allergic to bactrim? Or all the same ingredients in both? Please help! Asked by Numbers Moustafa 1 year ago.

They are the same drug, actually a combination of two drugs. Bactrim and Septra are two different brand names for the generic drug combination of sulfamethoxazole and trimethoprim Answered by Vannesa Dufauchard 1 year ago.


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